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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K993141
Device Name AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
Applicant
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Correspondent Contact CARL A MONGIOVI
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/21/1999
Decision Date 11/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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